Effects of empagliflozin on heart failure patients
Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure
This study tests if empagliflozin, a diabetes medication, can help people with worsening heart failure feel better over six weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT05553938 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of empagliflozin, a medication used to treat diabetes, on patients experiencing worsening heart failure. It involves 60 participants who will be randomly assigned to receive either empagliflozin or a placebo for six weeks, followed by a crossover phase where those on placebo will switch to empagliflozin. The study aims to evaluate changes in body fluid spaces, sodium retention, and various biomarkers related to heart and kidney function. The design allows for a thorough analysis of the medication's impact on heart failure symptoms and management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of worsening heart failure and a history of diuretic use.
Not a fit: Patients requiring hospitalization for heart failure at the time of randomization will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into the management of heart failure, potentially improving treatment options for patients.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific application of empagliflozin in heart failure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A clinical diagnosis of worsening heart failure (worsening of congestive symptoms with current therapies) in the opinion of the investigator. * A planned outpatient diuretic intervention (either up-titration of loop or addition of thiazide diuretic) for worsening heart failure per treating clinician. Diuretic intervention can occur via an unplanned in person visit (e.g., outpatient ambulatory clinic, emergency department, same day access visit) or via a telephone encounter (e.g., patient calling the clinic with reported weight gain and SOB that is prescribed uptitration of diuretic therapy). * Estimated or reported weight gain of at least 5 lbs. * Chronic daily oral loop diuretic dose ≥ 20mg furosemide equivalents for at least one month prior to enrollment * Estimated GFR (eGFR) ≥ 20 mL/min/1.73 m2 * Age ≥ 18 years old * Signed informed consent * English speaking participants only Exclusion Criteria: * Need for heart failure hospitalization at the time of randomization * Current use or plan to initiate renal replacement therapy * Significant bladder dysfunction or urinary incontinence * Inability to comply with the serial urine collection procedures * Chronic use of natriuretic doses of thiazide diuretics (≥50mg hydrochlorothiazide or equivalent) * Critical stenotic valvular disease, complex congenital heart disease or prior heart transplant * History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months * History of or current urosepsis or frequent urinary tract infections * Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) or active bleeding * Pregnancy or breastfeeding * Appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease)
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Testani, MD — Yale University
- Study coordinator: Veena Rao, PHD
- Email: veena.s.rao@yale.edu
- Phone: 2037373571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.